US8313013B2 - Method and assembly for anastomosis - Google Patents

Method and assembly for anastomosis Download PDF

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Publication number
US8313013B2
US8313013B2 US11/399,222 US39922206A US8313013B2 US 8313013 B2 US8313013 B2 US 8313013B2 US 39922206 A US39922206 A US 39922206A US 8313013 B2 US8313013 B2 US 8313013B2
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United States
Prior art keywords
joinable
clamp
assembly according
parts
assembly
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US11/399,222
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English (en)
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US20070239180A1 (en
Inventor
William F. Kuester, III
Tracy Konobeck
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Bio Vascular Inc
Synovis Life Technologies Inc
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Bio Vascular Inc
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Priority to US11/399,222 priority Critical patent/US8313013B2/en
Assigned to SYNOVIS LIFE TECHNOLOGIES, INC. reassignment SYNOVIS LIFE TECHNOLOGIES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KONOBECK, TRACY, KUESTER, WILLIAM F., III
Priority to CA2583398A priority patent/CA2583398C/fr
Priority to EP07105647A priority patent/EP1842495A3/fr
Publication of US20070239180A1 publication Critical patent/US20070239180A1/en
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Publication of US8313013B2 publication Critical patent/US8313013B2/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1103—Approximator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels

Definitions

  • the invention relates to a method and assembly for anastomosis.
  • Anastomosis is the joining of two vessels together to establish fluid communication between them.
  • One approach to accomplish this coupling has been to provide a surgical instrument having a clamp carrying a fastener.
  • the clamp generally has two members, each carrying a portion of the fastener that pivots towards each other to close the fastener.
  • each portion of the fastener includes a ring having axially directed pins and corresponding pin receiving holes.
  • the invention provides a method, an assembly, and various assembly components as described herein useful for joining two vessel ends and establishing a liquid connection between them, i.e., anastomosis.
  • the assembly can be used for end-to-end vessel anastomosis, end-to-side anastomosis and arterial/venous interpositional vein grafts.
  • the size of the vessels that can be joined with some embodiments of the assembly range from about one half millimeter (mm) to about 5 mm or larger in outer diameter.
  • the assembly of this invention permits the use of joinable parts having larger diameters and/or longer pins than those presently available, since the assembly permits the pins and corresponding apertures to be positioned in a substantially axial relationship at the time of coupling essentially regardless of the manner or angle at which the clamp portions of the clamp carrying the respective parts may approach each other.
  • conventional clamps and fasteners have generally relied upon the use of relatively smaller diameter parts, or smaller pins, or both, such that the parts could be coupled with little concern for the contacting angle between the parts themselves.
  • An apparatus of this invention permits the opposing faces of both fastener parts to be positioned substantially parallel to each other at the point of contact, in turn, such that their respective apertures and pins can be generally aligned in an axial manner upon closure.
  • the apparatus can achieve this result in any suitable manner, relying on any combination of the relative movement of the first and second parts toward each other, and/or the configuration of the clamp with respect to the fastener parts, and/or the relative sizes, shapes, and/or configurations of the fastener parts themselves.
  • the apparatus provides for movement of the respective parts toward each other at a predetermined angle relative to the clamp.
  • the respective joinable parts are themselves provided with varying thickness to permit substantial alignment of their opposing faces at the time of closure.
  • the apparatus is adapted to move the corresponding parts in a substantially parallel manner in the course of their coupling (e.g., translational movement). Yet other embodiments can include aspects of some or all of these approaches.
  • the assembly is particularly well suited for use in aligning first and second joinable parts that, given the relative position and dimensions of the parts and their pins, would otherwise not be suitably aligned if provided upon and closed by a conventional pivoting clamp.
  • the present assembly thereby permits larger joinable parts and/or longer pins to be held by a single clamp, yet manipulated in a surgical fashion to permit the parts to align at an appropriate time.
  • Such an assembly allows for the use of a greater range of fastener sizes, including both fastener diameter, pin length, and pin diameter.
  • the greater range of fastener sizes allows for the optimization of the fastener size with respect to the application.
  • the assembly allows the use of larger fasteners without unnecessarily increasing the size of the overall assembly, thereby making the assembly amenable for use in the surgical site.
  • the invention includes an assembly having a clamp adapted to hold a fastener part at an angle relative to the clamp, but does not include the fastener per se.
  • the invention includes a fastener with joinable parts provided with varying thickness to permit substantial alignment of their opposing major faces at the time of closure, but does not include the remainder of the assembly per se.
  • some embodiments of the invention include a vessel coupled together by an anastomotic joint provided in the manner described herein.
  • the assembly can then be activated to move the two joinable parts towards each other.
  • the assembly is adapted to facilitate the alignment of the joinable parts as described herein. Once the joinable parts meet, the pins of one joinable part can align with the receiving apertures of the opposite joinable part. Continued actuation of the assembly will cause the joinable parts to join and the anastomosis will be complete. The fastener can then be removed from the clamp and the assembly can be removed from the surgical area.
  • FIG. 1 provides a perspective view of an assembly in accordance with an embodiment of the invention.
  • FIG. 2 provides a top plan view of a clamp and fastener in accordance with an embodiment of the invention.
  • FIG. 3 provides a top plan view of an assembly in accordance with an embodiment of the invention.
  • FIG. 4 provides a front perspective view of a clamp and fastener in accordance with an embodiment of the invention.
  • FIG. 5 provides a rear perspective view of a clamp and fastener in accordance with an embodiment of the invention.
  • FIG. 6 provides a rear plan view of a clamp and fastener in accordance with an embodiment of the invention.
  • FIG. 7 provides a perspective view of an assembly in accordance with an embodiment of the invention.
  • FIG. 8 provides a top plan view of a fastener in accordance with an embodiment of the invention.
  • FIG. 9 provides a schematic representation of a geometric configuration of an assembly in accordance with an embodiment of the invention.
  • FIG. 10 provides a schematic representation of a prior art device.
  • FIG. 11 provides a perspective view of an assembly in accordance with an embodiment of the invention.
  • FIG. 12 provides a perspective view of an assembly in accordance with an embodiment of the invention.
  • FIG. 13 provides a perspective view of an actuator in accordance with an embodiment of the invention.
  • FIG. 15 provides a plan view of an actuator in accordance with an embodiment of the invention.
  • the invention provides a method and assembly for anastomosis.
  • the assembly includes a clamp and a fastener having first and second joinable parts, and the assembly can be adapted to facilitate the alignment of the first and second joinable parts. Such facilitation of alignment allows for the use of optimum sized fasteners without unnecessarily or unduly increasing the size of the overall assembly.
  • FIG. 1 illustrates an assembly of the invention useful for joining two vessels with a fastener.
  • the assembly is adapted to facilitate the alignment of two joinable parts of a fastener to more efficiently perform an anastomosis.
  • the assembly 10 includes a clamp 20 .
  • Clamp 20 can comprise any suitable feature, such as a first clamp portion 30 and a second clamp portion 40 .
  • a carrier rod 42 that generally follows the longitudinal axis of the assembly 10 can support first and second clamp portions 30 , 40 .
  • the first and second clamp portions 30 , 40 can be hingedly connected to the assembly 10 .
  • the clamp 20 is adapted to support a fastener 50 .
  • the clamp can contain one or more slots 52 useful for receiving a fastener 50 .
  • the slot 52 can include a guide element useful for orientating the fastener within the slot 52 .
  • the fastener 50 can comprise any suitable structure for joining two ends of a vessel together.
  • the fastener 50 includes a first joinable part 60 and a second joinable part 70 .
  • first joinable part 60 can be carried by first clamp portion 30 and second joinable part 70 can be carried by second clamp portion 70 .
  • each joinable part 60 , 70 can themselves comprise any suitable feature useful to allow them to join together and establish a fluid communication between the two vessels.
  • each joinable part 60 , 70 can include a generally disc-type shape having an opposing face 72 and a plurality of pins 80 and receiving apertures 90 sized and shaped to receive a corresponding pin circumferentially disposed around the disc.
  • the pins and corresponding receiving apertures can be equally circumferentially spaced around the disc.
  • the disc can have a diameter of more than about 3.5 millimeters (mm), and in other embodiments can have a diameter of more than about 4 mm.
  • the disc can have a diameter of more than about 5 mm (e.g., up to about 10 mm). Further, in some embodiments the distance from the center of the disc to the carrier rod 42 is between about 2 mm and about 10 mm. In some embodiments the distance from the center of the disc to the carrier rod 42 is between about 3 mm and about 7 mm (e.g., about 3.81 mm and about 6.35 mm). In embodiments where the joinable parts 60 , 70 pivot towards each other, such discs can create large angles between the joinable parts 60 , 70 .
  • the pin 80 can include any shape suitable for mating with receiving aperture 90 .
  • pin 80 can include a generally elongate member.
  • any number of pins 80 can be provided.
  • eight or more pins 80 (and a corresponding number of receiving apertures 90 ) are provided on each joinable part 60 , 70 .
  • the pins can have any suitable diameter and exposed length.
  • the pins can have a diameter of up to about 0.05 mm.
  • the pin can have a diameter of about 0.015 mm. In other embodiments, the pins have a diameter of about 0.0175 mm.
  • the pins have a diameter of about 0.02 mm. Further, the pins can have an exposed length of up to about 2 mm. In some embodiments, the pins have an exposed length of about 0.9 mm. In other embodiments, the pins have an exposed length of about 1.2 mm. In yet other embodiments, the pins have an exposed length of about 1.4 mm.
  • the assembly 10 can include a clamp 20 and a fastener 50 with first and second joinable parts 60 , 70 , and the assembly 10 can be adapted to facilitate the alignment of the first and second joinable parts.
  • the assembly can be adapted to reduce the angle between the first and second joinable parts 60 , 70 as they move towards each other, including reducing the angle towards zero degrees and having the first and second joinable parts translate towards each other.
  • the assembly 10 can be adapted to facilitate the alignment of the first and second joinable parts 60 , 70 in any suitable manner that orientates the opposing faces of the joinable parts in a substantially parallel configuration at the point of mating the two joinable portions, such as, for example, at the point where the tips of the pin 80 first contact its corresponding receiving aperture 90 .
  • the clamp 20 can be adapted to facilitate the alignment of the first and second joinable parts 60 , 70 , such as by holding one or more of the first and second joinable parts at an angle relative to the clamp.
  • one or more of the first and second joinable parts include a varying thickness to promote alignment.
  • the assembly can have dual plane clamps. Other embodiments include assemblies having more than one of these features to facilitate alignment.
  • the present invention provides an assembly for anastomosis employing a clamp and a fastener having first and second joinable parts carried by respective first and second clamp portions of the clamp, wherein the joinable parts each provide a respective opposing face providing pins extending axially therefrom and receiving apertures adapted to be mated axially with corresponding pins from the other opposing face.
  • the respective diameters of the opposing faces and pin lengths being such that the joinable parts cannot be suitably aligned if positioned upon a clamp having straight clamp portions joined by a simple pivot point located between about 2 mm to about 10 mm from the center of the faces.
  • Applicant provides an assembly that is nevertheless adapted to align and join the joinable parts.
  • FIGS. 2-7 show various views of clamps 20 can be adapted to facilitate the alignment of the first and second joinable parts 60 , 70 by holding the first and second joinable parts at an angle.
  • each of the first and second clamp portions 30 , 40 can have a clamp portion plane CPP.
  • each of the first and second joinable parts 60 , 70 can have a joinable part plane JPP.
  • the clamp portion plane CPP and the joinable part plane JPP are skewed relative to each other so as to facilitate alignment, as shown in FIGS. 2 and 3 .
  • angle SA can be defined as the angle between the clamp portion plane CPP and the joinable part plane JPP, as shown in FIGS. 2 and 3 .
  • Angle SA can be of any magnitude to facilitate alignment. In some embodiments, angle SA is more than about one degree. In other embodiments, angle SA is more than about three degrees. In yet other embodiments, angle SA is more than about 5 degrees. In yet other embodiments, angle SA is more than about 7 degrees. In yet other embodiments, angle SA is about 10 degrees.
  • the magnitude of the angle SA can depend on one or more of the distance between the joinable parts and the pivot point joining planes CPP, the size of the joinable parts 60 , 70 , the size and number of pins 80 , if included, the method by which the joinable parts are brought together, the relative diameters of pins and corresponding apertures, and the particular application.
  • first and second joinable parts 60 , 70 include a varying thickness to promote alignment, as shown in FIG. 8 .
  • the joinable part can have a first thickness D 1 at a first location, such as proximate the carrier rod 42 .
  • the joinable part can also have a second thickness D 2 at a second location, such as distal of the carrier rod 42 .
  • the second thickness D 2 is greater than the first thickness D 1 .
  • the varying thickness can provide the desired angle SA between the clamp portion plane CPP and the joinable part plane JPP as described above. Such a configuration reduces the angle between the first and second joinable parts 60 , 70 and thereby facilitates alignment.
  • FIGS. 9 and 10 The geometric relationship between the clamp portion plane CPP and the joinable part plane JPP are represented schematically in FIGS. 9 and 10 .
  • FIG. 9 shows an exaggerated schematic geometric relationship in accordance with an embodiment of the invention
  • FIG. 10 shows an exaggerated representative schematic geometric relationship of a prior art device having approximately the same general size. As shown in FIG.
  • embodiments of the invention that include an angle SA between the clamp portion plane CPP and the joinable part plane JPP, whether by the clamp portion holding the joinable part at an angle or by providing a joinable part with varying thickness, facilitates the alignment of the joinable portions of the fastener by allowing the opposing faces of the joinable parts to be substantially parallel at the point where the tips of the pin 80 first contact its corresponding receiving aperture 90 (not depicted in FIGS. 9 and 10 ).
  • prior art devices with approximately sized clamp portions and pin size that rely on an unmodified pivoting action will not align and the joinable parts will not be able to join, as shown in FIG. 10 .
  • the assembly 10 can have more than one of the features discussed herein.
  • the clamp 20 can be adapted to facilitate the alignment of the first and second joinable parts 60 , 70 , such as by holding one or more of the first and second joinable parts at an angle and one or more of the first and second joinable parts can include a varying thickness to promote alignment.
  • the assembly can have dual plane clamps and one or more of the clamp 20 adapted to facilitate the alignment of the first and second joinable parts 60 , 70 , such as by holding one or more of the first and second joinable parts at an angle and one or more of the first and second joinable parts can include a varying thickness to promote alignment.
  • the various embodiments of assemblies 10 discussed herein can be actuated by any suitable manner, such as by an actuator 130 .
  • the dual plane clamp assemblies shown in FIGS. 11 and 12 can be actuated by an actuator 130 having a guide 140 , as shown in FIGS. 13 and 14 .
  • the guide can be moved longitudinally about the assembly 10 so that the guide 140 interacts with the first and second clamp portions 30 , 40 to move them towards each other.
  • the guide 140 can move the first and second clamp portions 30 , 40 towards each other until they have been moved together completely, (e.g., the pins 80 of one joinable part being engaged with the corresponding receiving apertures 90 in the opposite joinable part).
  • guide 140 includes a first curved surface 142 adapted to orientate first and second joinable parts parallel to each other.
  • a second curved surface 144 is provided to translate the first and second joinable portions towards each other after they are parallel.
  • FIG. 14 shows an embodiment of this type of action.
  • FIG. 14 shows the clamps 30 and 40 in three different positions along the actuator 130 . In the first position, the clamps 30 and 40 are not engaged with the guide 140 and remain open and nonparallel. In the second position, the clamps are engaged with the guide and are oriented parallel to each other. In the third position, the clamps have been moved together.
  • the clamp 20 can also be opened and/or closed by actuation (e.g., longitudinal movement) of a guide 140 (e.g., bushing and/or cam) having a generally curved surface.
  • the clamp can be closed by actuation of the guide 140 .
  • the guide can be moved longitudinally about the assembly 10 so that the guide 140 interacts with the first and second clamp portions 30 , 40 to move them towards each other until they have been moved together completely, (e.g., the pins 80 of one joinable part being engaged with the corresponding receiving apertures 90 in the opposite joinable part).
  • a pusher connected with guide 140 will push the joined fastener out of the clamp, thereby leaving a joined vessel and allowing the rest of the assembly to be removed from the surgical area.
  • guide 140 can be moved longitudinally by the relative movement between a carrier rod 42 and one or more guiding rods 150 .
  • the first and second members of the clamp are rotatably coupled to a carrier rod 42 parallel with the longitudinal axis of the assembly.
  • one or more guide rods 150 parallel with the carrier rod 42 can be fixed to the guide 140 and a handle 160 .
  • the carrier rod 42 can be threadingly engaged with the handle 160 , and when the handle is turned the carrier rod is moved longitudinally relative to the guide rods 150 and guide 140 .
  • a biasing member 156 e.g. a spring
  • FIG. 7 may be provided to bias the clamp portions away from each other.
  • the invention also includes methods of using and making any of the various assemblies discussed herein.
  • an end of a vessel can be threaded through an aperture within a first joinable part of a fastener.
  • Another end of a vessel can be threaded through a second joinable part of the fastener.
  • Each vessel end can then be anchored to its respective joinable part by directing pins carried by the joinable part through the vessel.
  • the joinable part can be received within the clamp before or after the vessel is threaded and anchored.
  • the assembly can then be activated to move the two joinable parts towards each other.
  • the assembly is adapted to facilitate the alignment of the joinable parts as described herein.
  • the pins of one joinable part can align with the receiving holes of the opposite joinable part. Continued actuation of the assembly will cause the joinable parts to join and the anastomosis will be complete. The fastener can then be removed from the clamp and the assembly can be removed from the surgical area.
US11/399,222 2006-04-06 2006-04-06 Method and assembly for anastomosis Active 2027-09-14 US8313013B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US11/399,222 US8313013B2 (en) 2006-04-06 2006-04-06 Method and assembly for anastomosis
CA2583398A CA2583398C (fr) 2006-04-06 2007-03-30 Methodes et ensemble pour anastomose
EP07105647A EP1842495A3 (fr) 2006-04-06 2007-04-04 Procédé et ensemble pour anastomose

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11/399,222 US8313013B2 (en) 2006-04-06 2006-04-06 Method and assembly for anastomosis

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US20070239180A1 US20070239180A1 (en) 2007-10-11
US8313013B2 true US8313013B2 (en) 2012-11-20

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US (1) US8313013B2 (fr)
EP (1) EP1842495A3 (fr)
CA (1) CA2583398C (fr)

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US20110319916A1 (en) * 2010-06-25 2011-12-29 Cheol Woong Kim Slot drive type anastomosis device
WO2020225603A1 (fr) 2019-05-07 2020-11-12 Easyflomicro Inc. Appareils d'anastomose de vaisseaux tubulaires et méthodes associées

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KR101011445B1 (ko) * 2008-04-11 2011-01-28 (주)트리플씨메디칼 기계식 관상기관 문합장치
KR100982581B1 (ko) 2008-08-12 2010-09-16 (주)트리플씨메디칼 회전병진이동방식의 관상기관 문합장치
KR101001625B1 (ko) 2008-08-13 2010-12-17 (주)트리플씨메디칼 기어식 관상기관 문합장치
US8603114B2 (en) 2008-09-23 2013-12-10 Triple-C Medical Corporation Anastomotic device for tubular organ
KR100994112B1 (ko) * 2008-09-23 2010-11-12 (주)트리플씨메디칼 구동체 및 종동체를 구비하는 관상기관 문합장치
KR100995794B1 (ko) 2008-09-25 2010-11-22 (주)트리플씨메디칼 구동기어들을 구비하는 관상기관 문합장치
US20100114292A1 (en) * 2008-10-31 2010-05-06 Vioptix, Inc. Vessel Extender
US20100114293A1 (en) * 2008-10-31 2010-05-06 Vioptix, Inc. Multibranch Vessel Extender
KR101027744B1 (ko) 2009-08-05 2011-04-07 (주)트리플씨메디칼 자동봉합장치
KR101114471B1 (ko) 2009-08-25 2012-02-15 (주)트리플씨메디칼 왕복식 자동봉합장치
US8348128B2 (en) * 2009-11-11 2013-01-08 Biorep Technologies, Inc. Anastomosis system and method
US8245897B2 (en) * 2010-01-26 2012-08-21 Zakease Surgical Inc. Stapling apparatus for performing anastomosis on hollow organs
KR101101116B1 (ko) 2010-04-12 2011-12-30 (주)트리플씨메디칼 겸자 방식 문합장치
ES2632190T3 (es) 2010-12-15 2017-09-11 Meteso Ag Dispositivo de anastomosis médica
KR101480227B1 (ko) * 2013-06-10 2015-01-09 계명대학교 산학협력단 관상기관의 문합 시술용 기구
WO2016076329A1 (fr) * 2014-11-14 2016-05-19 日本発條株式会社 Dispositif d'anastomose vasculaire
WO2024020411A2 (fr) * 2022-07-18 2024-01-25 Dignity Health Systèmes et procédés pour un dispositif de distribution d'élément de fixation actionné manuellement

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US20110319916A1 (en) * 2010-06-25 2011-12-29 Cheol Woong Kim Slot drive type anastomosis device
US8777970B2 (en) * 2010-06-25 2014-07-15 Triple-C Medical Corporation Slot drive type anastomosis device
WO2020225603A1 (fr) 2019-05-07 2020-11-12 Easyflomicro Inc. Appareils d'anastomose de vaisseaux tubulaires et méthodes associées
US11751876B2 (en) 2019-05-07 2023-09-12 Easyflomicro Inc. Apparatuses for anastomosis of tubular vessels and related methods

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CA2583398A1 (fr) 2007-10-06

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